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Efficacy of pregabalin in the treatment of pancreatic cancer pain.

Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004397-28-ES
Enrollment
Unknown
Registered
2011-12-07
Start date
2012-01-25
Completion date
Unknown
Last updated
2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer induced abdominal pain

Interventions

Trade Name: Lyrica hard capsules Product Name: Pregabalin Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pregabalin CAS Number: 148553-50-8 Current Sponsor code: Pregabalin Other descriptive

Sponsors

Consorci Mar Parc de Salut de Barcelona (Parc de salut MAR)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients > 18 years old recently diagnosed of pancreatic cancer (=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. Patients with evidence or history of medical or surgical disease of importance fot this study as judged by investigator. 2. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) < 60 mL/min should be excluded. 3. Patients treated with anticonvulsants during the previous 4 months. 4. Patients showing hypersensitivity to the active drug or any its excipients as described in pregabalin drug sheet. 5. Pregnant women not using efficacious method of contraception and women in breastfeeding period.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the analgesic efficacy of pregabalin in pancreatic cancer induced abdominal pain;Secondary Objective: 1. To analyze the effect on quality of life of treatment with the co-analgesic pregabalin in pancreatic cancer patients. 2. To compare adverse effects induced by pregabalin to those induced by conventional treatment (WHO cancer pain recommendations). 3. To evaluate anxiety and depression in pancreatic cancer patients treated with pregabalin and to compare it with patients treated conventionally (WHO cancer pain recommendations).;Primary end point(s): Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI).;Timepoint(s) of evaluation of this end point: Visit 1 : baseline/randomization: day 0. Visit 2: day +30. Visit 3: day +60. Visit 4: day +90.—

Secondary

MeasureTime frame
Secondary end point(s): 1. Changes in quality of life compared to baseline level using SF-12 quality of life questionnaire. 2. Performance status (Karnofsky Performance Status Scale). 3. Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).;Timepoint(s) of evaluation of this end point: Visit 1 : baseline/randomization: day 0. Visit 2: day +30. Visit 3: day +60. Visit 4: day +90.—

Countries

Spain

Contacts

Public ContactServei de Recerca

Fundació Institut Mar d'Investigacions Mèdiques (IMIM)

recerca@imim.es3493316 06 70

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026